聚乙二醇化重组人粒细胞刺激因子预防化疗所致发热性中性粒细胞缺乏症的快速卫生技术评估

Rapid Health Technology Assessment of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor for the Prevention of Chemotherapy-Induced Febrile Neutropenia

目的:快速评估聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)预防化疗所致发热性中性粒细胞缺乏症(FN)的有效性、安全性和经济性,为卫生决策者及临床实践提供循证证据。方法:系统检索中英文数据库和卫生技术评估(HTA)相关网站,根据纳入与排除标准筛选文献,提取数据,评价文献质量并分析。结果:共纳入5篇Meta分析和5篇药物经济学研究文献。结果显示,在临床疗效方面,与重组人粒细胞刺激因子(rhG-CSF)比较,使用PEG-rhG-CSF可降低FN发生率,缩短FN恢复时间,但差异的统计学结论不稳定。在Ⅲ/Ⅳ度中性粒细胞减少发生情况方面,与rhG-CSF比较,使用PEG-rhG-CSF患者的Ⅳ度中性粒细胞减少发生率较低,Ⅳ度中性粒细胞减少持续时间较短,但差异无统计学意义(P>0.05);使用PEG-rhG-CSF与使用rhG-CSF患者的中性粒细胞绝对计数恢复时间比较,差异无统计学意义(P>0.05)。在安全性方面,与rhG-CSF比较,使用PEG-rhG-CSF患者的骨痛或骨骼肌痛的发生率较低,但差异无统计学意义(P>0.05)。PEG-rhG-CSF在经济性方面没有优势。结论:PEG-rhG-CSF在每个化疗周期仅需用药1次,在预防化疗所致FN的疗效和安全性方面都有一定的优势,不劣于rhG-CSF;目前其临床治疗不具有经济性。有必要开展不同的肿瘤疾病和不同的化疗方案的临床研究,以完善相关证据。

OBJECTIVE: To rapidly evaluate the efficacy, safety and economics of pegylated recombinant human granulocyte colony-stimulating factor(PEG-rhG-CSF) in the prevention of febrile neutropenia(FN) induced by chemotherapy, so as to provide evidence-based evidence for health policy makers and clinical practice. METHODS: Chinese and English databases and health technology assessment(HTA) organization websites were searched. According to inclusion and exclusion criteria, literature were screened, data was extracted, literature quality was evaluated and analyzed. RESULTS: A total of 5 Meta-analyses and 5 pharmacoeconomic assessments were included. In terms of clinical efficacy, compared with recombinant human granulocyte colony-stimulating factor(rhG-CSF), the use of PEG-rhG-CSF could reduce the incidence of FN and shorten the recovery time of FN, yet the statistical conclusion of the difference was unstable. In terms of the incidence of grade Ⅲ/Ⅳ neutropenia, patients with PEG-rhG-CSF had lower incidence of grade Ⅳ neutropenia and shorter duration of grade Ⅳ neutropenia compared with rhG-CSF, yet the difference was not statistically significant(P>0.05). There was no significant difference in the recovery time of absolute neutrophil count between patients with PEG-rhG-CSF and rhG-CSF(P>0.05). In terms of safety, compared with rhG-CSF, PEG-rhG-CSF patients had lower incidence of bone pain and skeletal muscle muscle pain, the difference was not statistically significant(P>0.05). The prevention of PEG-rhG-CSF had no economic advantages. CONCLUSIONS: PEG-rhG-CSF only needs to be administered once per chemotherapy cycle, and it has certain advantages in the efficacy and safety of prevention of FN induced by chemotherapy, which is not inferior to rhG-CSF;its current clinical treatment is not economical. It is necessary to carry out clinical research on different tumor diseases and different chemotherapy regimens to improve the relevant evidence.